Summary Impact Type

Research Subject Area(s)

Download original

Summary of the impact

Atrial fibrillation (AF) is the commonest heart rhythm abnormality,
affecting around 8.8 million people in the European Union, and conferring
a substantial risk of stroke and death. Up to 2% of the UK population,
some 1.2 million individuals, take oral anticoagulation medication.

The University of Birmingham is an internationally-respected centre of
excellence for research in AF, and has made crucial impacts in
international clinical practice guidelines and improvements in patient
care. Primary care research at the University of Birmingham has led to the
transfer of oral anticoagulation services from secondary to primary care,
and latterly patient self-management, resulting in improved clinical
outcomes. In addition, the BAFTA trial has provided evidence to support
the use of anticoagulation therapy (warfarin) for people aged over 75 who
have atrial fibrillation, resulting in changes in clinical management of
these patients.

Underpinning research

Around 2% of the UK population take oral anticoagulation (mainly warfarin
in the UK) with around 75% of these having atrial fibrillation (AF) as the
main indication. AF increases in prevalence with age and presents in 12%
of people aged over 75 years; 56% of patients with this arrhythmia are
over the age of 75. AF is a major risk factor for stroke, leading to a
five-fold increase in risk. As risk of stroke increases with age, stroke
prevention in elderly people with atrial fibrillation is a key aspect of
management for this group. Anticoagulation therapy with warfarin is highly
effective in reducing stroke risk but is associated with monitoring costs
and higher risk of haemorrhage compared with other treatments. Work on
this area has focused on service re- design, screening and treatment for
AF and has included generation of robust primary evidence through RCTs
[1-5], economic evaluation [4,6] and systematic review [6].

In 1999, UoB's primary care grouping within UoA2 began the SMART
(Self-Management of Anticoagulation: a Randomised Trial) study (PI: Fitzmaurice,
£285K, MRC, 1999-2002). SMART demonstrated the effectiveness of
self-management for approximately 25% of patients receiving warfarin,
compared with routine care whether provided through primary or secondary
care [2]. These data were the first UK RCT data and the first in the world
from primary care and have underpinned subsequent meta-analyses
demonstrating the clinical and cost-effectiveness of this model of care
(Garcia-Alamino et al Cochrane review 2010). Different models of managing
long- term oral anticoagulation therapy have also been assessed [6]. More
recently the Patient Self- Management registry (PI: Fitzmaurice
£50k, NIHR National School for Primary Care Research 2011-2014) has been
developed. As more people undertake self-monitoring or self- management of
their oral anticoagulation it is important to ensure that therapeutic
control is maintained. This electronic central register provides a
valuable tool for studying the safety and effectiveness of this method of
service delivery. This study is evaluating the feasibility of patients
with AF who self- monitor or self-manage their conditions entering their
data onto a website to produce a register.

Screening for AF

The Screening for Atrial Fibrillation in the Elderly (SAFE) study (Fitzmaurice
(PI), Hobbs,Mant, £485k HTA funded 1999-2003) was
a trial of systematic screening (targeted and total population screening)
versus routine practice for the detection of AF in 15,000 patients aged
over 65 [3,4]. SAFE determined the optimal method of AF diagnosis &
ECG interpretation [3] and established the incremental cost-effectiveness
(Jowett) of different screening options compared with routine
clinical practice, determining that opportunistic screening was most
cost-effective [4].

Management of AF

Meta-analysis has demonstrated that anticoagulants are significantly more
effective than aspirin at preventing stroke, but that this benefit is at
the cost of higher risk of major bleeding (van Walraven C, Hart RG, Singer
DE, Laupacis A, Connolly S, Petersen P et al. Oral anticoagulants vs
aspirin in nonvalvular atrial fibrillation: an individual patient
meta-analysis. JAMA 2002 ; 288(19) : 2441-8.). However, there were
concerns as to the applicability of this research to elderly patients with
AF, particularly in primary care settings.

In view of these uncertainties, the primary care grouping within UoB's
UoA2 conducted the BAFTA (Birmingham Atrial Fibrillation Treatment of the
Aged) study (PIs: Fitzmaurice,Hobbs, £740k MRC,
1999-2004). This compared the efficacy of warfarin with that of aspirin
for the prevention of stroke in a primary care population of 973 patients
with AF aged 75 years or over.

The effect on stroke prevention reported in the BAFTA study [5] was
similar to that reported in the 2002 meta-analysis. However, the key
difference between the two results is that the meta-analysis showed a
doubling of risk of major haemorrhage in people on oral anticoagulants
compared with those on aspirin, whereas the BAFTA study found no such
difference. The BAFTA study provided accurate data on the risk of
haemorrhage, which appears to be an important factor in physicians'
decisions whether to prescribe warfarin. In addition, the study
demonstrated the actual benefits of warfarin compared to aspirin and
reported data showing improved efficacy and equivalent safety of warfarin
versus aspirin in stroke prevention in the very elderly. The study
provided evidence to support the use of anticoagulation therapy (warfarin)
for people aged over 75 with AF unless there are contraindications or the
patient chooses otherwise [5].

Details of the impact

Shifting delivery of anticoagulation services

Impact on Clinical Practice and Patient Health

Primary care research within UoB UoA2 has led to the transfer of oral
anticoagulation services from secondary to primary care, and latterly
patient self-management resulting in improved clinical outcomes for
patients throughout the 2008-13 REF impact period. The Birmingham Model
for oral anticoagulation management (a primary care based service
utilising near patient testing and computerised decision support software)
was adopted within the NHS through the inclusion of anticoagulation
services as a Nationally Enhanced Service (NES) within the GP contract in
2004 (GSM Contract for Anticoagulation in Primary Care). The research also
informed the 2006 recommendations of the NHS National Patient Safety
Agency on making anticoagulation therapy safer, recommendations that are
still current [1] and that have, together with the contract changes,
enabled transfer of oral anticoagulation management from secondary to
primary care, leading to significant improvements in both patient
experience and clinical outcome.

Changes in the management of AF

Impact on Public Policy

SAFE demonstrated the effectiveness of opportunistic screening for AF in
UK primary care, whilst BAFTA established superior efficacy and safety of
warfarin as compared to aspirin in patients aged 75 and over. These
studies have influenced the UK policy framework during the 2008-13 REF
impact period, both through clinical guidelines and NHS GP contracting.
Clinical guidelines published in 2011 by The British Committee for
Standards in Haematology `Guidelines on oral anticoagulation' 2011 [2]
recommend computer assisted dosing, referencing the Computerised Decision
Support research. The work has also informed the increasing awareness of
AF as a serious cause of morbidity and has directly influenced indicators
within the NHS Quality and Outcomes Framework throughout the REF period,
with indicators to directly influence, through funding arrangements,
provision of anti-coagulation drug therapy for AF patients [3, 4].

Impact on UK Clinical Practice and Patient Health

There has been impact on patient management throughout the 2008-2013 REF
impact period resulting from the policy changes described above, but also
from important NICE guidelines that were produced prior to this, but were
still current during this time. The 2006 NICE National Atrial Fibrillation
Clinical Guideline for Management in Primary and Secondary Care [5]
references the SAFE study. This guidance remained current throughout the
period 2008-2013.

Impact on International Policy and Clinical Practice

As well as influencing UK clinical practice, the work of the Birmingham
team has also influenced guidelines in Europe and the USA: These include:
the European Society of Cardiology guidelines, produced in 2010 and
updated in 2012 [6] — the updated guidelines, referencing the work of the
Birmingham group, indicated that "We therefore recommend that, in
patients aged 65 years or over, opportunistic screening for AF by pulse
palpation, followed by recording of an ECG to verify diagnosis, should
be considered for the early detection of AF"; the European Stroke
Organisation Guidelines for the Management of Ischaemic Stroke and
Transient Ischaemic Attack, 2008 [7]; the American College of Chest
Physicians guidelines, June 2008 [8].

Impact on Education and CPD

Research in this area has led to the establishment of the National Centre
for Anticoagulation Training within UoB, which provides accredited
training for health care professionals involved in the management of
patients receiving anticoagulation treatment [9]. 42 CPD courses were run
between January 2008 and June 2013, with 1,234 participants.

Following publication of the research on anticoagulation Fitzmaurice
and Murray have provided two in-depth learning modules for the BMJ
available from 2008 (Fitzmaurice, Cousins, Clark) and updated (Fitzmaurice,
Murray) during the 2008-13 period [10]. BMJ Learning offers
high-quality (peer reviewed, up-to-date, and evidence-based) continuing
medical education in an economical and time efficient manner, for general
practitioners, hospital doctors and other healthcare professionals. The
anticoagulation modules are accredited by a number of associations,
including Australian Practice Nurses Association, Austrian Academy of
Physicians, The Royal New Zealand College of General Practitioners, The
Colleges of Medicine of South Africa, Oman Medical Specialty Board, and
Kuwait Institute for Medical Specialization. Comments on BMJ Learning
suggest the modules are received positively.

Screening for AF

This work has informed the increasing awareness of AF as a serious cause
of morbidity and there is on-going work within the NHS Health Improvement
Service to improve detection of AF with parallel efforts being undertaken
to ensure optimum treatment of those patients with appropriate therapy
[11]. The SAFE & BAFTA trials have resulted in a debate (2012) amongst
the Royal College of Physicians around developing a national screening
programme for AF [12].